RG1.168 核电厂安全系统中使用的数字计算机软件的验证、确认、审查和监查 2004

RegulatoryguidesareissuedtodescribeandmakeavailabletothepublicsuchinformationasmethodsacceptabletotheNRCstaffforimplementingspecificpartsoftheNRC’sregulations,techniquesusedbythestaffinevaluatingspecificproblemsorpostulatedaccidents,anddataneededbytheNRCstaffinitsreviewofapplicationsforpermitsandlicenses.Regulatoryguidesarenotsubstitutesforregulations,andcompliancewiththemisnotrequired.MethodsandsolutionsdifferentfromthosesetoutintheguideswillbeacceptableiftheyprovideabasisforthefindingsrequisitetotheissuanceorcontinuanceofapermitorlicensebytheCommission.Thisguidewasissuedafterconsiderationofcommentsreceivedfromthepublic.Commentsandsuggestionsforimprovementsintheseguidesareencouragedatalltimes,andguideswillberevised,asappropriate,toaccommodatecommentsandtoreflectnewinformationorexperience.WrittencommentsmaybesubmittedtotheRulesandDirectivesBranch,ADM,U.S.NuclearRegulatoryCommission,Washington,DC20555-0001.Regulatoryguidesareissuedintenbroaddivisions:1,PowerReactors;2,ResearchandTestReactors;3,FuelsandMaterialsFacilities;4,EnvironmentalandSiting;5,MaterialsandPlantProtection;6,Products;7,Transportation;8,OccupationalHealth;9,AntitrustandFinancialReview;and10,General.Singlecopiesofregulatoryguides(whichmaybereproduced)maybeobtainedfreeofchargebywritingtheDistributionServicesSection,U.S.NuclearRegulatoryCommission,Washington,DC20555-0001,orbyfaxto(301)415-2289,[e-mail]ideandotherrecentlyissuedguidesareavailableatNRC’shomepageat(DraftwasissuedasDG-1123)VERIFICATION,VALIDATION,REVIEWS,ANDAUDITSFORDIGITALCOMPUTERSOFTWAREUSEDINSAFETYSYSTEMSOFNUCLEARPOWERPLANTSA.INTRODUCTIONIn10CFRPart50,“DomesticLicensingofProductionandUtilizationFacilities,”paragraph50.55a(a)(1)requires,inpart,thatstructures,systems,andcomponentsbedesigned,tested,andinspectedtoqualitystandardscommensuratewiththeimportanceofthesafetyfunctiontobeperformed.InAppendixA,“GeneralDesignCriteriaforNuclearPowerPlants,”to10CFRPart50,Criterion1,“QualityStandardsandRecords,”requires,inpart,thataqualityassuranceprogrambeestablishedandimplementedinordertoprovideadequateassurancethatstructures,systems,andcomponentsimportanttosafetywillsatisfactorilyperformtheirsafetyfunctions.AppendixB,“QualityAssuranceCriteriaforNuclearPowerPlantsandFuelReprocessingPlants,”to10CFRPart50describescriteriathatmustbemetbyaqualityassuranceprogramforstructures,systems,andcomponentsthatpreventormitigatetheconsequencesofpostulatedaccidents.Inparticular,besidesthestructures,systems,andcomponentsthatdirectlypreventormitigatetheconsequencesofpostulatedaccidents,thecriteriaofAppendixBalsoapplytoallactivitiesaffectingthesafety-relatedfunctionsofsuchstructures,systems,andcomponents,suchasdesigning,purchasing,installing,testing,operating,maintaining,ormodifying.Aspecificrequirementiscontainedin10CFR50.55a(h)(2)thatprotectionsystemsinnuclearpowerplantswithconstructionpermitsissuedafterJanuary1,1971,butbeforeMay13,1999,mustmeettherequirementsstatedineitherIEEEStd279,“CriteriaforProtectionSystemsforNuclear1IEEEpublicationsmaybeobtainedfromtheIEEEServiceCenter,445HoesLane,Piscataway,NJ08854.2Revision1ofRegulatoryGuide1.153,CriteriaforSafetySystems,endorsesIEEEStd603-1991,CriteriaforSafetySystemsforNuclearPowerGeneratingStations,asamethodacceptabletotheNRCstaffforsatisfyingtheNRC’sregulationswithrespecttothedesign,reliability,qualification,andtestabilityofthepower,instrumentation,andcontrolportionsofthesafetysystemsofnuclearpowerplants.1.168-2PowerGeneratingStations,”1orinIEEEStd603-1991,“CriteriaforSafetySystemsforNuclearPowerGeneratingStations,”andthecorrectionsheetdatedJanuary30,1995.1,2TheNRCstaffconsidersIEEEStd279-1971tomeettherequirementsin10CFR50.55a(h)(2).ProtectionsystemsinnuclearpowerplantswithconstructionpermitsissuedbeforeJanuary1,1971,aretobeconsistentwiththeirlicensingbasisormaymeettherequirementsofIEEEStd603-1991andthecorrectionsheetdatedJanuary30,1995.ProtectionsystemsinapplicationsfiledonorafterMay13,1999,aretomeettherequirementsforsafetysystemsinIEEEStd603-1991andthecorrectionsheetdatedJanuary30,1995.Clause4.3ofIEEEStd279-1971statesthatthequalityofcomponentsistobeachievedthroughthespecificationofrequirementsknowntopromotehighquality,suchasrequirementsfordesign,inspection,andtest.Clause5.3ofIEEEStd603-1991statesthatcomponentsandmodules(ofsafetysystems)mustbeofaqualitythatisconsistentwithminimummaintenancerequirementsandlowfailurerates.Safetysystemequipmentmustbedesigned,manufactured,inspected,installed,tested,operated,andmaintainedinaccordancewithaprescribedqualityassuranceprogram.NotethatguidanceontheapplicationofthesecriteriaforsafetysystemequipmentemployingdigitalcomputersandprogramsorfirmwareisfoundinIEEEStd7-4.3.2-1993,“StandardCriteriaforDigitalComputersinSafetySystemsofNuclearPowerGeneratingStations,”1whichisendorsedbyRevision1ofRegulat